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Orthopedic and Dental Industry News Complete Archive »

Clinical Studies

Researchers Develop a New Delivery Approach for Bone Regeneration BY ANDREW VAHRADIAN, AUGUST 28, 2014

A team of researchers at MIT have developed a new approach to bone regeneration and reconstruction called "layer-by-layer assembly". The approach utilizes a very thin, porous, nanostructured, biodegradable poly(lactic-co-glycolic acid) scaffold sheet that incorporates a polyelectrolyte multilayer coating containing active... more

Stem Cell Therapy Halts DDD BY ANDREW VAHRADIAN, MARCH 21, 2014

Meta-analysis of pre-clinical animal studies concluded that stem cell transplant was effective treatment in halting or reversing degenerative disc disease (DDD) of the spine. The study demonstrated that stem cell therapy not only increased intervertebral disc (IVD) height, but also... more

Researchers Develop Novel Approach to Grow Cartilage BY ANDREW VAHRADIAN, FEBRUARY 26, 2014

In a recent study published in the Proceedings of the National Academy of Sciences, a team of Duke University biomedical engineers developed a polymer scaffold that utilizes gene therapy vectors to induce stem cells to create the required growth factor... more

Medtronic Presents 7-year Clinical Data for Artificial Disc Replacement BY ANDREW VAHRADIAN, DECEMBER 12, 2013

Medtronic presented 7-year clinical and radiographic outcomes of artificial disc replacement procedures with its PRESTIGE Cervical Disc, which is a stainless steel device that articulates through a ball and trough mechanism. The study enrolled a total 541 patients and compared... more

FDA Permits Reviews of Wright Medical and FzioMed Biologic Products BY ANDREW VAHRADIAN, NOVEMBER 19, 2013

Wright Medical and FzioMed received notifications from the FDA agreeing to withdraw its not approvable letters and establish Medical Dispute Resolution Panels (DRP) for the companys' Augment Bone Graft and Oxiplex Gel products respectively. Wright's Augment product is intended for... more

rhBMP-2 Linked to Higher Rates of Benign Tumor Development BY ANDREW VAHRADIAN, SEPTEMBER 13, 2013

In recent years, the use bone morphogenetic proteins (BMPs) has come under scrutiny. A study published in Spine, found a rise in the prevalence of off-label use of BMPs, determining that between 2003 and 2007, the annual number of procedures... more

Chinese Research Team Conducting Study on 3D Printed Spinal Implants BY ANDREW VAHRADIAN, AUGUST 15, 2013

At the Peking University Third Hospital in Beijing, Dr. Liu Zhongjun, Chairman of the Department of Orthopedic surgery and the Research Center of Spinal Surgery, Peking University, is leading a team of researchers in the process of conducting human clinical... more

FDA to Conduct Study on Metal-on-Metal Hip Implant Corrosion BY ANDREW VAHRADIAN, AUGUST 13, 2013

In order to close a loophole in the Medical Device Amendments of 1976, the federal law under which medical devices were first regulated, the FDA issued a proposed order in January that required metal-on-metal (MoM) hip arthroplasty implant manufacturers to... more

Wright Medical Receives Not Approvable Decision from the FDA for its Augment Bone Graft Product BY ANDREW VAHRADIAN, AUGUST 9, 2013

Wright Medical announced that it received a not approvable letter from the FDA in response to its Pre-Market Approval (PMA) application for its Augment Bone Graft, intended for use as an alternative to autograft in hindfoot and ankle fusion procedures.... more

Bioactive Glass Scaffolds Demonstrate Potential as Weight-bearing Implants BY ANDREW VAHRADIAN, AUGUST 1, 2013

Researchers at Missouri University of Science and Technology have developed a type of glass implant that could one day be used to repair injured bones in the arms, legs and other areas of the body that are most subject to... more

Cholesterol-lowering Statins Could Lead to Musculoskeletal Injuries BY ANDREW VAHRADIAN, JUNE 25, 2013

A report published by JAMA Internal Medicine determined that while utilizing cholesterol-lowering statins can lower cardiovascular illnesses and death, it could also lead to musculoskeletal arthropathies and injuries associated with a wide variety of clinical presentations, including muscle weakness, muscle... more

Medtronic Announces the Publication of the Yale Review of INFUSE BY ANDREW VAHRADIAN, JUNE 19, 2013

Medtronic announced the publication of two highly anticipated independent reviews overseen by Yale University regarding its INFUSE Bone Graft product, the company's proprietary formulation of recombinant human bone morphogenetic protein-2 (rhBMP-2). The results of both analyses, published in the June... more

Musculoskeletal News Roundup 23-May-2013 BY LAUREN UZDIENSKI, MAY 23, 2013

MDT reports earnings ... OsteoGeneX receives SBIR grant ... FDA panel votes to reclassify pedicle screws for the thoracolumbosacral class II ... Depuy Synthes to discontinue ULTAMET Metal-on-Metal Articulation and COMPLETE Ceramic-on-Metal hip systems ... KFx receives new patents ... Benvenue Medical completes follow-up for KAST study ... Globus files suit against Depuy Synthes ... Blue Belt partners with DJO ... EOS announces Asia expansion ... Stryker and OrthoSensor extend co-marketing agreement for VERASENSE more

Researchers Develop Material with the Potential to Promote Bone Formation BY ANDREW VAHRADIAN, FEBRUARY 11, 2013

Researchers at the Universities of Edinburgh and Southampton have discovered an amalgamation utilizing stem cells and a new lightweight plastic that can support bone formation. In the study, published in Advanced Functional Materials, the researchers determined that by combining bone... more

Researchers Conclude the "July Effect" is Negligible on Spinal Surgery BY ANDREW VAHRADIAN, FEBRUARY 6, 2013

Researchers concluded that the storied "July Effect", which claims that patients receive a lower standard of care due to the introduction of new residents and fellows at teaching hospitals during the month of July, has an negligible effect on periprocedural... more

SPORT Data Demonstrates Obese Patients Realize Less Clinical Benefit from Treatment of Lumbar Disc Herniation BY ANDREW VAHRADIAN, JANUARY 3, 2013

It has been well documented that obesity exacerbates the strain exerted on and deterioration of a person's musculoskeletal system, and leads to a greater probability of lower back pain, facet arthritis and degenerative disc disease. Though, the link between obesity... more

Musculoskeletal News Roundup 20-Sept-2012 BY LAUREN UZDIENSKI, SEPTEMBER 20, 2012

K2M receives expanded 510(k) clearance for MESA portfolio ... ATEC announces first clinical use of NEXoss ... DJO launches Movation TKA ... KFx announces new patent ... Lanx announces ASPEN MIS results more

Musculoskeletal News Roundup 2-Aug-12 BY LAUREN UZDIENSKI, AUGUST 2, 2012

ANIK, ARTC, DJO, EXAC, MAKO, RTIX, SNN, SMA, WMGI report 2Q:12 ... Medtronic launches Aquamantys3 BSC 9.1S Bipolar Sealer with Cutting ... NewVert completes biomechanical testing for Octopus Spinal Annular Repair System ... Spinal Elements introduces Lucent Ti-Bond ... Benvenue Medical completes KAST enrollment ... TranS1 announces study results more

Musculoskeletal News Roundup 19-Jul-12 BY LAUREN UZDIENSKI, JULY 19, 2012

Biomet, JNJ, Stryker announce earnings ... Mindray closes Dragonbio acquisition ... K2m debuts Rail 4D Technology ... Globus files amended S-1 ... MTF receives patent covering NovaBone Putty ... Expanding Orthopedics announces data presentation ... SpineGuard reports 6-month data ... Cardinal Health launches Orthopedic Solutions offering more

Musculoskeletal News Roundup 28-Jun-12 BY LAUREN UZDIENSKI, JUNE 28, 2012

Benvenue raises $25M ... ZMH launches TM Ardis Interbody System for the lumbar spine ... Cartiva completes enrollment for their MOTION trial ... Corin expands LARS distribution agreement ... IART debuts private label version of the aap Implantate stainless headed compression screw system more

Musculoskeletal News Roundup 24-May-12 BY LAUREN UZDIENSKI, MAY 24, 2012

Medtronic reports earnings ... AxioMed closes Series D round ... Mazor launches C-OnSite ... BlueCross BlueShield of Tennessee announces bundled payments for hip and knee replacements ... Baxano completes enrollment on iO-Flex study ... Benvenue announces Board appointments more

Musculoskeletal News Roundup 17-May-12 BY LAUREN UZDIENSKI, MAY 17, 2012

aap, Corin, Mazor, TiGenix provide 1Q sales ... Regenerative Sciences raises $2M ... Regentis Biomaterials raises $10M ... Zyga raises $25M ... Axiomed receives CE mark for Freedom Cervical Disc ... Orthopaedic Implant Company launches pedicle screw system ... DOJ closes InFuse investigation ... Histogenics, Piramal announce cartilage repair data more

Clinical Roundup May 2012 BY LAUREN UZDIENSKI, MAY 10, 2012

Use of fibrin sealant QUIXIL in TKAs ... The accuracy of imaging in spine surgery ... ACL revision data from Denmark ... Ankle surgery and weight loss ... More surgeons working for hospitals more

Musculoskeletal News Roundup 3-May-12 BY LAUREN UZDIENSKI, MAY 3, 2012

ARTC, DJO, EXAC, KNSY, NUVA, SNN, SMA, WMGI report 1Q:12 ... Titan Spine announces publication of data ... VG Innovations awarded new patent ... Solco Biomedical announces U.S. distribution deal more

Musculoskeletal News Roundup 19-Apr-12 BY LAUREN UZDIENSKI, APRIL 19, 2012

JNJ, Stryker announce earnings ... EU approves JNJ's acquisition of Synthes ... DePuy launches VIPER F2 Transfacet Pedicular System ... IART introduces Vu aPOD Prime IBD ... Mesoblast reaches 50% enrollment on phase II study ... OREF announces $3.1 million in grants more

Musculoskeletal News Roundup 12-Apr-12 BY LAUREN UZDIENSKI, APRIL 12, 2012

Biomet kicks off earnings season ... FDA approves phase I Arteriocyte study for Compartment Syndrome ... Piramal receives CE mark for BST-CarGel ... Amedica announces new biologics distribution agreements ... Advanced Biologics inks deal with GPO Premier more

Musculoskeletal News Roundup 5-Apr-12 BY LAUREN UZDIENSKI, APRIL 5, 2012

SNN acquires LifeModeler ... Cutting Edge Spine launches E-Vol System of spinal fusion devices ... Medtronic to settle shareholder lawsuit for $85M ... New BONESUPPORT CEO announces 100 Day Plan ... Blue Belt opens new Pittsburgh facility more

Musculoskeletal News Roundup 22-Mar-12 BY LAUREN UZDIENSKI, MARCH 22, 2012

KH reports earnings ... Tepha raises $11M ... Anulex resolves FDA warning letter ... IART launches PyroTITAN Humeral Resurfacing Implant ... Benvenue Medical begins enrollment on Luna Interbody System study more

Musculoskeletal News Roundup 15-Mar-12 BY LAUREN UZDIENSKI, MARCH 15, 2012

BMTI reports 4Q11 ... Interventional Spine to present PerX360 System at ISASS ... DFINE announces first implantation of STAR System ... Simpirica Spine receives FDA approval for pivotal study ... Mazor Robotics signs distribution agreement for China more

Dental Roundup February 2011 BY LAUREN UZDIENSKI, MARCH 13, 2012

Dentsply, Nobel, Straumann announce earnings ... Align launches Invisalign Outcome Simulator ... Glidewell announces Inclusive portfolio launches ... Zimmer Dental launches Trabecular Metal Dental Implant ... Swedish study shows 92% dental implant survival rate at 18 years ... Nobel Biocare announces that Michel Orsinger will not assume role of Chairman more

Musculoskeletal News Roundup 8-Mar-12 BY LAUREN UZDIENSKI, MARCH 8, 2012

Corin, MAKO report earnings ... NLT Spine raises $5.7M ... Baxano receives CE mark for iO-Flex ... Synthes receives FDA warning letter ... Amedica launches Procet Facet Allograft Implant ... Crosstrees Medical completes enrollment in IDE study for VCF treatment ... Titan Spine creates EU subsidiary ... Vexim establishes German subsidiary more

Clinical Roundup February 2012 BY LAUREN UZDIENSKI, FEBRUARY 27, 2012

Defining conservative treatment in VCF cases ... Obesity and large joint outcomes ... Optimizing TKR rehab ... Navigation in TKR ... A review of PRP data ... Predicting recovery of walking ability in hip fracture patients more

Musculoskeletal News Roundup 2-Feb-12 BY LAUREN UZDIENSKI, FEBRUARY 2, 2012

EXAC, KNSY, RTIX, SNN announce 4Q:11 ... CartiHeal raises $5M ... ConforMIS raises $89M ... FDA clears Eden Spine's GIZA device ... NLT announces 510(k) clearance for the PROW FUSION TLIF device ... ThermoGenesis announces "encouraging" study results more

Musculoskeletal News Roundup 12-Jan-12 BY LAUREN UZDIENSKI, JANUARY 12, 2012

MAKO, NUVA, OFIX, SYK, TRNX pre-announce ... FDA clears Biomet's E1 humeral bearing and Comprehensive Segmental Revision System ... Ortho Kinematics receives 510(k) clearance ... Lanx announces 100th implantation of Durango ... Mazor receives EU patent ... SNN announces VISIONAIRE study ... Arthrex to market ThermoGenesis PRP, bone marrow concentrate product ... Pioneer Surgical promotes Daniel Webber to CEO more

Musculoskeletal News Roundup 22-Dec-11 BY LAUREN UZDIENSKI, DECEMBER 22, 2011

Biomet pre-announces . . . Oregon judge throws out SNN suture anchor ruling . . . Exactech initiates cartilage repair study . . . Spine Wave and MB Innovations announce partnership more

Musculoskeletal News Roundup 8-Dec-11 BY LAUREN UZDIENSKI, DECEMBER 7, 2011

Mazor reports earnings . . . HealthpointCapital acquires Blue Belt Technologies . . . DFINE receives regulatory clearance in Canada and Mexico . . . LDR approved to market ROC-C cervical cage, ROI-A ALIF cage in China . . . Ranier receives CE mark for Cadisc-C . . . DePuy launches Expedium Neuromuscular System . . . Exactech extends DPA . . . CA sobpoenas MDT over Infuse . . . IART opens China office . . . JNJ names Michel Orsinger worldwide chairman of its Global Orthopedics Group more

Musculoskeletal News Roundup 23-Nov-11 BY LAUREN UZDIENSKI, NOVEMBER 23, 2011

MDT reports F2Q . . . TSON gives reimbursement update . . . Expanding Orthopedics comments on XPED expandable pedicle screw study . . . NREF and OREF to establish Collaborative Spine Research Foundation more

Musculoskeletal News Roundup 17-Nov-11 BY LAUREN UZDIENSKI, NOVEMBER 17, 2011

Zimmer acquires ExtraOrtho and XtraFix External Fixation System . . . FDA clears X-spine's Calix PC . . . TranS1 launches lateral access fusion system . . . DFINE initiates post-market study more

Musculoskeletal News Roundup 3-Nov-11 BY LAUREN UZDIENSKI, NOVEMBER 3, 2011

ATEC, ARTC, EXAC, IART, WMGI and more announce 3Q . . . FDA clears LDR's ROI-A Oblique ALIF cage . . . ATEC, Custom Spine, Globus, K2M, Medtronic and others debut new products at NASS . . . Relievant MedSystems starts enrolling SMART trial . . . Spine Wave starts EU NuCore study more

Robust New Study Draws Link between Spinal Patients and Postoperative Complications BY SANDER DUNCAN, SEPTEMBER 28, 2011

A new study published in JBJS determined several independent predictors of mortality for spine surgery patients, including old age, infected wounds, and duration of the operation. The study is notable for its robust patient-based data set, encompassing 3,475 patients undergoing several spinal procedures over a four year time frame. more

Musculoskeletal News Roundup 4-Aug-11 BY LAUREN UZDIENSKI, AUGUST 4, 2011

ATEC, ANIK, ARTC, BMTI, EXAC, SNN, SMA announce earnings . . . Ellipse Technologies announces series C round . . . CMS announces IPPS final rule . . . KFx Medical sues Arthrex . . . Tornier initiates IDE study more

Dental News Roundup - July 2011 BY MATTHEW JAFFE, JULY 29, 2011

Dentsply and Zimmer Dental announce earnings . . . Straumann makes investment in Dental Wings . . . Study shows cavities, missing teeth correlated to diabetes more

Musculoskeletal News Roundup 28-Jul-11 BY LAUREN UZDIENSKI, JULY 28, 2011

CNMD, IART, NUVA, OFIX, RTIX, WMGI and ZMH report 2Q . . . FDA releases draft guidance on device modifications . . . Osseon launches in India . . . Carbylan Biosurgery announces results from viscosupplement study . . . Lanx comments on data at IMAST more

Musculoskeletal News Roundup 30-Jun-11 BY LAUREN UZDIENSKI, JUNE 30, 2011

Stryker completes Orthovita tender offer . . . ConforMIS to raise $68M . . . FDA clears Corin's highly cross-linked polyethylene liners and large diameter CoCr and BIOLOX Delta Ceramic heads . . . Aesculap launches Hydrolift Vertebral Body Replacement System . . . Cayenne Medical debuts the CrossFix II Meniscal Repair System . . . Mesoblast receives FDA clearance to begin phase II DDD study more

Musculoskeletal News Roundup 9-Jun-11 BY LAUREN UZDIENSKI, JUNE 9, 2011

Brainlab to acquire Voyant Health . . . FDA clears ARTC's Spartan 6.5 Needled Anchor . . . Mazor Robotics launches next-gen Renaissance system . . . DFINE comments on VCF study results . . . Senators request investigation of PODs . . . Arteriocyte announces army stem-cell research project more

Musculoskeletal News Roundup 28-Apr-11 BY LAUREN UZDIENSKI, APRIL 28, 2011

CNMD, IART, SYST, ZMH and more report earnings . . . FDA clears Biomet's Active Articulation E1 Dual Mobility Hip System . . . ORTHOCON receives EU, Canadian clearance to market HEMASORB . . . SI-BONE receives modification to its labeling . . . DJO Global introduces e-plus total knee replacement insert . . . Wright Medical launches FUSIONFLEX Demineralized Moldable Scaffold . . . Kuros regains certain technology rights from Baxter . . . Genzyme files two new HA infringement suits more

Musculoskeletal News Roundup 14-Apr-11 BY LAUREN UZDIENSKI, APRIL 14, 2011

FDA approves Covidien's DuraSeal Exact . . . IART announces new spine clearances . . . Lanx launches facet screw system and ALIF system . . . Tornier introduces BioFiber Surgical Mesh . . . VITA comments on positive Vitagel data . . . Stryker sues Zimmer for allegedly poaching sales force more

Musculoskeletal News Roundup 24-Mar-11 BY LAUREN UZDIENSKI, MARCH 24, 2011

China Kanghui reports earnings, announces acquisition . . . FlexFix to acquire assets from Novalign . . . Newly-formed Rachiotek to acquire Applied Spine Technologies . . . Core Essence raises $11.5M . . . LDR submits PMA for two-level Mobi-C . . . FDA clears TSON's AxiaLIF 1L+ . . . FDA approves Seikagaku's single-injection HA . . . Pioneer Surgical launches the the Streamline TL Spinal Fixation System . . . Spinal Kinetics announces 10,000th implantation of M6 Disc . . . Medtronic of Canada releases data from study on kyphoplasty in cancer patients . . . Zimmer signs Department of Defense contract more

Musculoskeletal News Roundup 17-Mar-11 BY LAUREN UZDIENSKI, MARCH 17, 2011

Biomedical Structures acquires Concordia Medical . . . Neue Magnetodyn IP to go up for auction . . . Wright Medical closes tender offer for convertible senior notes . . . K2M receives CE mark for RAVINE Lateral Access and ALEUTIAN Lateral Interbody Systems . . . Smith & Nephew files suit against former employees . . . OrthAlign comments on new clinical data . . . Misonix, Aesculap sign new distribution agreement . . . Shukla Medical licenses Kytogenics' biopolymer technology . . . Inion resumes operations . . . DePuy Spine appoints worldwide president more

Musculoskeletal News Roundup 10-Mar-11 BY LAUREN UZDIENSKI, MARCH 10, 2011

ANIK, BMTI, VITA report 4Q . . . Global Biotech to take minority position in BoneGrafix . . . ConforMIS to raise $1.8M . . . Medtronic launches ATLANTIS VISION ELITE cervical plate system . . . Wright Medical launches PRO-TOE VO . . . OFIX receives subpoena . . . Vertos announces mild clinical data . . . GenOsteo and SpineSmith to collaborate on stem cell scaffold . . . RegeneCure licenses synthetic membrane for use with stem cells . . . Bacterin now trading on NYSE Amex more

Musculoskeletal News Roundup 24-Feb-11 BY LAUREN UZDIENSKI, FEBRUARY 24, 2011

ATEC, MDT, NUVA report on 4Q spine market . . . IART, SMA report 4Q:10 . . . Mazor Robotics raises $6.3M . . . FDA clears Zimmer's TM-S Trabecular Metal Cervical Interbody Fusion Device . . . Smith & Nephew receives premium reimbursement in Japan for Oxinium hip . . . Intrinsic Therapeutics enrolls first patient in Barricaid study for anular closure . . . Zimmer reports clinical results for DeNovo NT Graft and the MotionLoc Screws more

Musculoskeletal News Roundup 17-Feb-11 BY LAUREN UZDIENSKI, FEBRUARY 17, 2011

ARTC, DJO, GENZ, OFIX and Synthes report earnings . . . Sonoma raises $22 million . . . Anika provides FDA update . . . AAOS product launches . . . Medtronic announces kyphoplasty data more

Musculoskeletal News Roundup 27-Jan-11 BY LAUREN UZDIENSKI, JANUARY 27, 2011

DJO, JNJ, SYK, ZMH report 4Q;10 . . . Arthrex acquires Cardo Medical's total joint assets . . . Flex Biomedical, OrthoSensor raise funding . . . LDR submits PMA for Mobi-C . . . Medtronic launches CD HORIZON SOLERA . . . Kuros releases one-year data from KUR-111 study . . . Gary Fischetti named group chairman for DePuy subsidiaries more

Musculoskeletal News Roundup 13-Jan-11 BY LAUREN UZDIENSKI, JANUARY 13, 2011

MAKO, NUVA, SYK pre-announce . . . Globus acquires Facet Solutions' assets . . . Doctors Research Group raises $7.7M . . . Wright Medical launches DARCO system in Japan . . . Zimmer introduces NexGen LPS-Flex Mobile Bearing Knee with Prolong Highly Crosslinked Polyethylene . . . FDA approves Wright Medical's IDE for the INBONE Total Ankle Replacement with Calcaneal Stem . . . China Kanghui Holdings and Consensus Orthopedics announce manufacturing and marketing agreement more

Musculoskeletal News Roundup 9-Dec-10 BY LAUREN UZDIENSKI, DECEMBER 9, 2010

SBi sells shoulder assets . . . Ortho Kinematics raises $2M . . . FDA clears VITA's Vitoss Bioactive Foam-2X . . . Life Spine announces first cases with the OCTAVE Posterior Fusion System . . . WMGI initiates limited rollout of the PRO-TOE VO Hammertoe Fixation System . . . BMTI begins enrollment on Augment Rotator Cuff pilot study . . . Audax Medical licenses biomaterial from Brown University . . . NeoStem entity to bring orthopedic stem cell treatments to Shijiazhuang, China . . . EXAC resolves DOJ investigation more

AAOS Launches Joint Registry Pilot Program BY LAUREN UZDIENSKI, OCTOBER 13, 2010

A national large joint registry championed by AAOS will be launched this month as a pilot program at 15 hospitals. The registry will track results based on details about patients, doctors, hospitals and implants with the aim of improving outcomes, and many large-joint manufacturers have voiced their support for the program. more

Musculoskeletal News Roundup 30-Sept-10 BY LAUREN UZDIENSKI, SEPTEMBER 29, 2010

InVivo Therapeutics planning a reverse merger . . . MiMedx to raise $5.0 million . . . FDA clears ArthroCare's Parallax device to treat VCFs . . . Osseon Therapeutics announces 1,000-patient milestone . . . AAOS releases clinical guidelines for vertebroplasty and kyphoplasty . . . ProChon reports BioCart Autologous Cartilage System outcomes . . . RepRegen releases in vivo StronBone data more

Musculoskeletal News Roundup 23-Sept-10 BY LAUREN UZDIENSKI, SEPTEMBER 23, 2010

M&A Amedica acquired US Spine for an undisclosed amount. The target company manufactures a range of fusion products as well as the Facet Fixation System, which features the Facet Gun to lock the facet joint. Amedica says that with the... more

Musculoskeletal News Roundup 26-Aug-10 BY LAUREN UZDIENSKI, AUGUST 26, 2010

Corin, Medtronic, TiGenix report . . . DePuy warned over TruMatch Personalized Solutions System and Corail Hip System . . . FDA clears Medyssey's Zenius Thoracolumbar Spinal System . . . Binder Biomedical launches NEWTON Intervertebral Body Spacer System . . . CareFusion launches AVAmax Vertebral Balloon . . . DePuy recalls ASR system . . . Benvenue Medical enrolls first patient in VCF study . . . MAKO Surgical appoints Director more

Musculoskeletal News Roundup 19-Aug-10 BY LAUREN UZDIENSKI, AUGUST 19, 2010

Medtronic to acquire Osteotech . . . Stryker may buy Boston Scientific's neuromodulation unit . . . SI-Bone raises $11M . . . Aesculap received 510(k) clearance for the A-Fix Spinal System . . . Biomet responds to FDA warning letter . . . Benvenue Medical announces first U.S. use of the Blazer system for treating VCFs . . . Cytori receives patent for stem cell use in musculoskeletal applications . . . NuOrtho Surgical announces pre-clinical results . . . RTI Biologics reports "no change" to Medtronic supply agreement more

Musculoskeletal News Roundup 29-Jul-10 BY LAUREN UZDIENSKI, JULY 29, 2010

CNMD, IART, NUVA, OFIX, Synthes report 2Q:10 sales . . . Axiomed raises $14.5M . . . China Kanghui Holdings to go public . . . FDA panel votes in favor of Medtronic's Amplify . . . FDA approves Orthovita's new collagen processing facility . . . curasan seeking distribution partners for ATR . . . TranS1 launches next-gen AxiaLIF 2L+ system . . . Ortho Kinematics enrolling study more

Relief for Low Back Pain Continues to be Elusive in Glucosamine Study BY LAUREN UZDIENSKI, JULY 7, 2010

A new study on glucosamine shows that the supplement has no effect on low back pain with degenerative lumbar osteoarthritis. more

Musculoskeletal News Roundup 10-June-10 BY LAUREN UZDIENSKI, JUNE 10, 2010

M&A The Quebec Superior Court authorized the sale of BioSyntech's assets to Piramal Healthcare. Piramal will acquire assets and assume certain BioSyntech liabilities for CAN $3.9 million ($3.7 million). The sale should close within 15 business days. Funding According to... more

Musculoskeletal News Roundup 3-Jun-10 BY LAUREN UZDIENSKI, JUNE 3, 2010

Mazor announces first German GO-LIF sales . . . OrthoDynamix launches the ArthroSteer Biter . . . Osprey Biomedical introduces the Eagle Cervical Allograft Series . . . DOJ settles with Idaho orthopedists . . . Stryker and Wright Medical settle knee infringement suit . . . Amedica awarded patent . . . AOFAS releases position paper on total ankle replacement . . . Pioneer Surgical announces NuBac data . . . RepRegen reports StronBone data . . . Medtronic to report physician payments greater than $5,000, and Steve La Neve steps down from spine & biologics more

Dental News Roundup May 2010 BY LAUREN UZDIENSKI, MAY 28, 2010

NADX's go-shop period ends . . . Smile Brands cancels its IPO . . . Sirona launches new products . . . Straumann receives award for Roxolid . . . Regenerating teeth from stem cells more

Musculoskeletal News Roundup 27-May-10 BY LAUREN UZDIENSKI, MAY 27, 2010

Medtronic announces FQ4 . . . Exactech acquires Brighton Partners, supplier of Optetrak knee material . . . VentureMD closes funding round . . . KFx cleared to market AppianFx knee products . . . X-spine receives FDA clearance for Fixcet Spinal Facet Screw System . . . Applied Spine awarded patents . . . DFine, Vertos release clinical data . . . curasan collaborates with Matricel on bone graft substitute . . . SpineGuard appoints Alan Olsen Chairman of the Board more

Musculoskeletal News Roundup 20-May-10 BY LAUREN UZDIENSKI, MAY 20, 2010

ANIK, SYK resolve FDA warning letters . . . FDA clears Mesoblast Phase II study . . . DePuy Mitek to launch Bristow-Latarjet Instability Shoulder System . . . OrthoX developing new bone cement . . . DOJ recovers $20 million in allegedly fraudulent kyphoplasty billings . . . SpineGuard signs European distributor . . . B1 collaborating with Invibio more

Musculoskeletal News Roundup 13-May-2010 BY LAUREN UZDIENSKI, MAY 13, 2010

aap Implantate, ATEC, ANIK, BMTI, OSTE report Q1 earnings . . . SBi announces Olympus investment . . . Aesculap launches pedicle screw system . . . data on B Braun's Targon screw . . . BioSyntech files for bankruptcy more

Musculoskeletal News Roundup 29-Apr-10 BY LAUREN UZDIENSKI, APRIL 29, 2010

CNMD, EXAC, OFIX, RTIX, Synthes announce Q1 results . . . Facet Solutions, IMPLANET announce funding rounds . . . Aesculap launches DBM-D . . . Applied Spine Technologies, Facet Solutions release study data . . . Flexuspine cleared to start IDE . . . Federal judge dismisses liability claim against Stryker . . . Cayenne Medical appoints CFO more

Musculoskeletal News Roundup 22-Apr-10 BY LAUREN UZDIENSKI, APRIL 22, 2010

GENZ, DePuy, NUVA, VITA, SYK, ZMH report 1Q:10 . . . Internal Fixation Systems, Soft Tissue Regeneration announce funding rounds . . . Smith & Nephew wins 510(k) clearance for additional VERILAST claims . . . First commercial use of Interventional Spine's RENEW interspinous process device . . . NUVA files legal dispute against OFIX over Osteocel IP . . . LDR completes follow-up on two-level Mobi-C study more

Musculoskeletal News Roundup 15-Apr-10 BY LAUREN UZDIENSKI, APRIL 15, 2010

Biomet kicks off earnings seasons . . . ATEC preannounces . . . Articulinx, biospace med, Osseon close funding rounds . . . ConforMIS G2 Uni receives CE mark clearance . . . EXAC's Novation hip approved for sale in Japan . . . Stryker Interventional Spine launches iVAS for VCFs . . . Cayenne Medical announces clinical results for the AperFix System more

Musculoskeletal News Roundup 8-Apr-10 BY LAUREN UZDIENSKI, APRIL 7, 2010

Earnings RSB Spine announced that 1Q:10 sales increased 25% over 4Q09. M&A Stryker closed its acquisition of assets related to Synergetics' Sonopet/Omni product line, an ultrasonic aspirator that has applications in neurosurgery. Synergetics will receive $2.5 to $3.0 million in... more

New Study Shows Dental Patients Experience Long Term Benefits from BioHorizons Dental Implants BY EDITOR, APRIL 7, 2010

banner_singlestage.gifBioHorizons reported today that a recently published study demonstrates that dentists who use Laser-Lok dental implants to replace missing teeth can give patients years of normal dental function and appearance. "This study is consistent with the results I have had for the last 10 years with Laser-Lok dental implants," said Dr. Cary Shapoff, the lead author of the study. more

JAMA Study Demonstrates Higher Costs and Complications for Older Fusion Patients BY LAUREN UZDIENSKI, APRIL 7, 2010

logo.225x76.gifA study published in the Journal of the American Medical Association this week suggested higher rates of complications and higher costs for Medicare patients who undergo complex spinal fusions (defined as more than two disc levels or combined anterior and posterior approach) compared to decompression procedures. While the study confirmed questions about complications and resource use in elderly patients, it did not consider outcomes measures, such as improvement in function or reduction in pain. more

Musculoskeletal News Roundup 1-Apr-10 BY LAUREN UZDIENSKI, APRIL 1, 2010

xray_small.jpgATEC closes Scient'x acquisition . . . Anulex and Carticept Medical close funding rounds . . . OrthAlign receives 510(k) clearance for its latest KneeAlign design . . . Eden Spine receive a European patent . . . Medicare cuts loom as Congress departs for Easter recess . . . ArthroCare reports data on their Plasma Disc Decompression products more

Dental News Roundup March 2010 BY LAUREN UZDIENSKI, MARCH 31, 2010

technician2_small.jpg FDA accepts PMA application from Ondine Biopharma Corporation, developers of the Periowave Photodisinfection System . . . Astra Tech launches OsseoSpeed TX implant line . . . Sirona introduces new 3D software for CEREC . . .Nobel Biocare provides clinical data on NobelActive, All-on-4 Solution and TiUnite . . . DTI, Nobel and Straumann strength management teams more

Musculoskeletal News Roundup 18-Mar-10 BY LAUREN UZDIENSKI, MARCH 18, 2010

doc_xray_small.jpgANIK, ATEC report 4Q:09 . . . ATEC shareholders approve Scient'x Acquisition . . . Non Linear Technologies, Spinal Restoration close funding rounds . . . CareFusion launches kyphoplasty balloon . . . Integra launches new products for spine . . . New vertebroplasty data released more

Musculoskeletal News Roundup: AAOS Edition BY LAUREN UZDIENSKI, MARCH 11, 2010

OR_small.jpg The latest news from AAOS! VITA and MAKO report 4Q09 . . . ETEX receives 510(k) . . . DePuy, Integra, Medtronic, Smith & Nephew and more announce product launches . . . SEC Drops Wright Medical Investigation . . . BioMimetic Therapeutics shares study results . . . Long-term use of bisphosphonates may increase fracture risk . . . NeoStem wins research grant more

Musculoskeletal News Roundup 4-Mar-10 BY LAUREN UZDIENSKI, MARCH 4, 2010

knee.jpg Corin, Osteotech and Integra report 4Q . . . Baxter to acquire ApaTech for up to $330.0 million . . . Intrinsic Therapeutics closes on $18.0 million of a $20.0 million round . . . FDA schedules Orthopaedic and Rehabilitation Devices Panel meeting for Menaflex . . . Aetna and United Healthcare reverse prior policies and announce that they will cover NuVasive's XLIF . . . Congress delays Medicare pay cut more

Dental News Roundup February 2010 BY LAUREN UZDIENSKI, FEBRUARY 26, 2010

biohorizons_product.jpgDentsply reported 4Q:09 sales of $568.7 million, up 12% over the year-ago period and beating estimates by $12.0 million. Chairman and CEO Bret Wise commented, "We are pleased to report stronger sales and earnings for the fourth quarter, as we are beginning to see the initial signs of recovery in select markets and regions." more

Musculoskeletal News Roundup 25-Feb-10 BY LAUREN UZDIENSKI, FEBRUARY 25, 2010

xray_small.jpgAlphatec Spine reported 4Q:09 revenues of $36.6 million, an increase of 29% from the $28.4 million reported in 4Q:08. U.S. revenues for the quarter were $28.3 million, an increase of 29% from the $22.0 million reported for 4Q:08. U.S. revenues for the quarter were $28.3 million, an increase of 29% from the $22.0 million reported for 4Q:08. Asian revenues were $6.6 million, an increase of 38% from the $4.8 million reported for 4Q:08. European revenues in 4Q:09 were $1.7 million. more

TKA Patients Gain More Weight Post-Op Compared to Healthy Controls BY LAUREN UZDIENSKI, FEBRUARY 23, 2010

Despite the increased mobility associated with total knee replacement, a new study found that TKA patients actually gain more weight post-operatively than non-surgical controls. The study, published in Osteoarthritis and Cartilage, enrolled 106 TKA patients and 31 non-surgical controls. The... more

Musculoskeletal News Roundup 18-Feb-10 BY LAUREN UZDIENSKI, FEBRUARY 18, 2010

Earnings DJO reported 4Q:09 revenues of $257.2 million, up 5% over 4Q:08, with domestic rehab sales up 3% and domestic surgical implant sales up 8%. The company attributed the latter largely to "strong sales of our Reverse Shoulder Prosthesis." Net... more

Musculoskeletal News Roundup 28-Jan-10 BY LAUREN UZDIENSKI, JANUARY 29, 2010

Earnings Johnson & Johnson reported 4Q:09 revenues of $16.5 billion, representing a 9% increase over the year-ago period and beating estimates by $0.8 billion. DePuy reported $1.5 billion in sales, up 10% over the year-ago period, with hip up 12%,... more

Dental News Roundup January 2010 BY LAUREN UZDIENSKI, JANUARY 28, 2010

We're listening. In response to your feedback on our 2009 readership survey, we're broadening the dental coverage on our blog. You can help by letting us know what you think or directing your press releases and scientific articles to Lauren... more

Musculoskeletal News Roundup 17-Dec-09 BY LAUREN UZDIENSKI, DECEMBER 17, 2009

M&A Alphatec Holdings, Inc. announced that it has entered into a definitive agreement to acquire Scient'x Groupe SAS, a spinal implant company headquartered in France. The transaction is structured as an all-stock transaction such that 100% of outstanding Scient'x stock... more

JBJS: The Latest in Adult Reconstructive Knee Surgery BY LAUREN UZDIENSKI, DECEMBER 11, 2009

This month JBJS published an overview from Drs. Carl Deirmengian and Jess Lonner on the latest clinical developments and trends in knee reconstruction. The paper was based on a review of new knee literature in 2008. Below is a summary... more

Kyphoplasty Safe and Effective for VCFs BY LAUREN UZDIENSKI, NOVEMBER 24, 2009

This month JBJS reprinted data from the Fracture Reduction Evaluation (FREE) study that had been published in the Lancet earlier this year (and discussed at NASS two weeks ago.) FREE researchers found that patients randomized to undergo kyphoplasty for the... more

Musculoskeletal News Roundup 19-Nov-09 BY LAUREN UZDIENSKI, NOVEMBER 19, 2009

Earnings ArthroCare restated its earnings from 2004 through 2Q:09. The company reported total revenue for 2008 of $314.2 million, up 12% over 2007. Relative to prior-year periods, 1Q:09 revenues increased 2% to $78.8 million; 2Q:09 revenues decreased 6% to $80.8... more

Musculoskeletal News Roundup 12-Nov-09 BY LAUREN UZDIENSKI, NOVEMBER 12, 2009

Earnings Alphatec Holdings, Inc. announced record consolidated revenue of $32.7 million in 3Q:09, which represents 27% growth over 3Q:08. U.S. revenue increased 21% over the prior-year third quarter and 28% over the first nine months of 2008. International revenue was... more

Musculoskeletal News Roundup 5-Nov-09 BY LAUREN UZDIENSKI, NOVEMBER 5, 2009

Earnings aap Implantate reported nine-month revenue of EUR 25.6 million ($37.4 million), which represents a 6% increase over the year-ago period. The company said third-quarter highlights included the signing of several IP agreements that emphasize orthopedics, trauma ad spine. Artimplant... more

Musculoskeletal News Roundup 29-Oct-09 BY LAUREN UZDIENSKI, OCTOBER 30, 2009

Earnings Anika Therapeutics reported 3Q:09 revenues of $10.1 million, representing an 18% increase over the year-ago period and missing estimates by $0.3 million. Joint Health sales, including the Orthovisc and Monovisc products, were up 31% to $6.1 million. Anika noted... more

Musculoskeletal News Roundup 22-Oct-09 BY LAUREN UZDIENSKI, OCTOBER 22, 2009

Earnings CONMED reported 3Q:09 sales of $175.5 million, down 2% from the year-ago period and beating estimates by $1.4 million. Arthroscopy sales were up 2% and powered instrument sales were flat. Non-GAAP diluted EPS of $0.28 beat estimates by $0.12.... more

Musculoskeletal News Roundup 15-Oct-09 BY LAUREN UZDIENSKI, OCTOBER 15, 2009

Earnings Biomet reported FQ1:10 revenues of $630.0 million, a 7% increase over the year-ago period. Excluding dental, recon sales increased by 9%, with knee up 10%, hip up 6% and extremity up 23%. Dental decreased by 5%. All rates exclude... more

Musculoskeletal News Roundup 24-Sept-09 BY LAUREN UZDIENSKI, SEPTEMBER 24, 2009

Funding MedShape Solutions closed a $10 million round of equity funding from unnamed private investors. The company will use the funds to develop its portfolio of PEEK-based shape-memory devices. An Indianapolis foundation granted $7.0 million for the creation of OrthoWorx,... more

Musculoskeletal News Roundup 17-Sept-09 BY LAUREN UZDIENSKI, SEPTEMBER 17, 2009

M&A Integra LifeSciences acquired the assets of Innovative Spinal Technologies, Inc. (IST) for $9.25 million in cash. Last year the company recorded $2.2 million in revenues, though they ceased operations in January and went into liquidation in May. This transaction... more

Musculoskeletal News Roundup Aug-27-09 BY LAUREN UZDIENSKI, AUGUST 27, 2009

Earnings Corin reported 1H:09 sales of GBP 20.1 million ($33.0 million), down 25% over 1H:08 after adjusting for currency and beating estimates by GBP 2.1 million ($3.5 million). Outside the U.S., revenues increased by 10%, which the company attributed to... more

Musculoskeletal News Roundup 20-Aug-09 BY LAUREN UZDIENSKI, AUGUST 20, 2009

Earnings aap Implantate reported 1H:09 sales of EUR 14.7 million ($20.7 million), representing a 10% decreased from 1H:08. Adjusting for one-time income, sales were down 3%, and in the second half of 2009, the company "anticipates a recovery in demand... more

Vertebral and Hip Fractures Associated with Increased Mortality Risk BY LAUREN UZDIENSKI, AUGUST 17, 2009

According to a study published in the Canadian Medical Association Journal, patients 50 and older who suffer vertebral and hip fractures may also have an increased risk of mortality. Results showed that 16% of people who develop a vertebral fracture... more

NEJM Studies Challenge the Efficacy of Vertebroplasty BY LAUREN UZDIENSKI, AUGUST 7, 2009

Two studies published this week in the New England Journal of Medicine cast doubts over the efficacy of vertebroplasty. The first study, conducted in Australia, randomized 78 patients in a multicenter, double-blind, placebo-controlled trial in which participants with one or... more

Musculoskeletal News Roundup 23-Jul-09 BY LAUREN UZDIENSKI, JULY 23, 2009

Earnings Anika Therapeutics reported 2Q:09 revenue of $9.5 million, representing a 5% increase over 2Q:08 and missing estimates by $0.4 million. The company attributed revenue growth to both the ORTHOVISC and MONOVISC product lines, which contributed $5.6 million to total... more

Musculoskeletal News Roundup 9-Jul-09 BY LAUREN UZDIENSKI, JULY 9, 2009

Earnings Exactech announced that 2Q:09 revenues would be approximately $43.0 million, below earlier guidance and analyst expectations of approximately $45.0 million. The range for full-year 2009 revenue guidance has also been lowered to $167-$173 million. The company attributed 2Q's sales... more

Musculoskeletal News Roundup 2-Jul-09 BY LAUREN UZDIENSKI, JULY 2, 2009

Earnings Biomet reported net sales of $639.0 million for FQ4:09, which represents an increase of 1% as reported and 7% when adjusting for currency. Among segments, recon, excluding dental, increased 3% as reported and 11% constant currency. Dental decreased by... more

BMPs Increase Complications for Cervical Fusion Patients BY LAUREN UZDIENSKI, JULY 1, 2009

A study published in JAMA reviewed use of BMPs in spinal fusion surgeries, and outcomes included higher complication rates for off-label use in cervical fusions and increased charges for all procedures. Researchers at Brigham and Women's Hospital in Boston conducted... more

Teriparatide and Raloxifene May Reduce Vertebral Fracture Risk BY LAUREN UZDIENSKI, JUNE 29, 2009

We reported back in April that teriparatide, a recombinant form of parathyroid hormone marketed by Eli Lilly as Forteo, may help bones to heal following a fracture. Now a new study published in JBJS reports on an additional application for... more

Musculoskeletal News Roundup 25-Jun-09 BY LAUREN UZDIENSKI, JUNE 25, 2009

Funding BioMimetic Therapeutics raised approximately $17.0 million in a rights offering that closed on Wednesday. The company offered 2,000,000 shares at $8.50 per share in May. The company plans to use the funds for general corporate purposes, including to product... more

Musculoskeletal News Roundup 18-Jun-09 BY LAUREN UZDIENSKI, JUNE 19, 2009

M&A The bankruptcy trustee for Innovative Spinal Technologies announced plans to pay creditors by selling the company's patent portfolio and other IP. The company's products include the AXIENT motion-preserving pedicle screw system; the PARAMOUNT MIS pedicle screw system; the PARAMOUNT... more

Increased Risk of Fracture in Bariatric Surgery Patients BY LAUREN UZDIENSKI, JUNE 18, 2009

Study data presented at the Endocrine Society's annual meeting revealed an unexpected trend in patients who undergo bariatric surgery: a dramatically increased risk of fractures. In a representative sample of 97 patients, most of whom underwent a gastric banding procedure,... more

New SPORT Data Favors Surgery for the Treatment of Spondylolisthesis with Stenosis BY LAUREN UZDIENSKI, JUNE 2, 2009

JBJS published data from the ongoing SPORT trial in this month's edition of the journal, and, like prior results from the study, patients who undergo spine surgery fare better than patients who don't. This arm of the analysis focused on... more

Musculoskeletal News Roundup 14-May-09 BY LAUREN UZDIENSKI, MAY 14, 2009

Earnings aap Implantate reported 1Q:09 revenues of EUR 8.4 million ($11.1 million), representing a 5% increase over the year-ago period. EBITDA for the quarter declined 47% to EUR 0.05 million ($1.1 million). The company says that for the full-year 2009,... more

Musculoskeletal News Roundup 30-Apr-09 BY LAUREN UZDIENSKI, APRIL 30, 2009

Earnings aap Implantate reported 2008 revenues of EUR 31.9 million ($45.0 million), a 14% increase over 2007 sales. Sales in the Trauma & Orthopedics division grew by 35%. Biomaterials sales increased by 4%, with the company attributing slower growth to... more

Musculoskeletal News Roundup 23-Apr-09 BY LAUREN UZDIENSKI, APRIL 23, 2009

Earnings CONMED reported 1Q:09 revenues of $164.1 million, representing a 7% decrease over 1Q:08 and missing estimates by $9.5 million. Arthroscopic devices contributed $63.9 million in revenue, down 8% over 1Q:08, with the decline due largely to a 24% decrease... more

Musculoskeletal News Roundup 9-Apr-09 BY LAUREN UZDIENSKI, APRIL 9, 2009

Earnings Biomet reported FQ3:09 revenues of $615 million, a 7% (constant currency) increase over FQ3:08. Among segments, recon reported growth of 7%, with hip up 10%, knee up 9%, fixation up 4% and dental down 10%, which the company attributed... more

Stryker's OP-1 Putty Not Approvable According to FDA Panel BY ARIELLA P. GOLOMB, MD, APRIL 1, 2009

Yesterday an FDA advisory panel voted 6-1 that Stryker's PMA for its OP-1 Putty for uninstrumented posterolateral fusion for the treatment of lumbar spondylolisthesis was "not approvable." Stryker was seeking this approval based on 24 months of clinical outcome data... more

Ozone Injections Could Reduce Back Pain BY LAUREN UZDIENSKI, MARCH 25, 2009

Yes, that ozone. The molecule that filters UV rays in the atmosphere and is a pollutant on the ground could have applications for reducing back pain, according to new studies out of Europe. Over the past five years, it is... more

Musculoskeletal News Roundup 19-Mar-09 BY LAUREN UZDIENSKI, MARCH 19, 2009

Earnings TiGenix announced 2008 financial results this week, reporting a widening net loss as the company prepares to launch ChondroCelect in Europe. The company's net loss was EUR 15.2 million ($21.4 million), an increase of 27% over 2007. As the... more

Musculoskeletal News Roundup 5-Feb-09 BY LAUREN UZDIENSKI, FEBRUARY 5, 2009

Earnings CONMED Corp. reported 4Q:08 revenues of $179.2 million, down 5% versus 4Q:07 and beating estimates by $2.26 million. Non-GAAP diluted earnings per share were $0.34, down 23% from 4Q:07 and beating estimates by $0.05. The company reported 4Q:08 arthroscopy... more

FDA, HHS Issue New Rules for IRBs BY ELOISE AUSTIN, FEBRUARY 4, 2009

A new set of companion regulations put in place on January 15, 2009 by the FDA and HHS Office for Human Research Protections (OHRP) will expand federal registration requirements for institutional review boards. Previously, the OHRP managed a registry of... more

Musculoskeletal News Roundup 22-Jan-08 BY LAUREN UZDIENSKI, JANUARY 22, 2009

Earnings aap Implantate pre-announced 4Q:08 and full-year 2008 revenues of EUR 7.1 million ($10.0 million) and EUR 31.2 million ($44.0 million), respectively. 4Q:08 revenues declined 24% from the year-ago period, which the company attributed to "more orders from global partners"... more

Musculoskeletal News Roundup 8-Jan-09 BY LAUREN UZDIENSKI, JANUARY 8, 2009

Earnings CONMED Corp. lowered 4Q:08 revenue projections to $176-$178 million, 9% lower than forecast and approximately 7% lower than 4Q:07. Reduced revenues were attributed to unfavorable foreign currency exchange fluctuations and lower than anticipated sales of capital equipment to hospitals.... more

SPORT Data Quantifies Cost-Effectiveness of Laminectomy, Fusion BY LAUREN UZDIENSKI, JANUARY 5, 2009

Using the data collected from the SPORT trial, researchers at Rush University Medical Center evaluated the cost-effectiveness of spinal surgery in stenosis patients with and without spondylolisthesis. The study considered the direct and indirect costs of laminectomy and fusion against... more

Musculoskeletal News Roundup 18-Dec-08 BY LAUREN UZDIENSKI, DECEMBER 18, 2008

Funding In addition to its regularly scheduled payments, Orthofix International will make a $10 million debt prepayment on December 29th in advance of the scheduled maturity. According to Executive Vice President and CFO Bob Vaters, "This is a good time... more

Musculoskeletal News Roundup 11-Dec-08 BY LAUREN UZDIENSKI, DECEMBER 12, 2008

Earnings Wright Medical reiterated 4Q:08 revenue and earnings guidance on a call this week and lowered 2009 guidance based on less favorable foreign exchange rates. The company is now calling for 2009 revenues in the range of $510 million to... more

For Patients in Pain, Scans May Not Offer a Diagnosis BY LAUREN UZDIENSKI, DECEMBER 9, 2008

Imaging technology may be an ubiquitous part of modern medical practice, but a New York Times article suggests that the frequency and sensitivity of MRI and CT scans may reveal musculoskeletal abnormalities without showing what causes a patient's pain. These... more

Musculoskeletal News Roundup 4-Dec-08 BY LAUREN UZDIENSKI, DECEMBER 4, 2008

Earnings Stryker announced a 2008 dividend of $0.40 per share, an increase of 21% over the 2007 dividend, which is payable January 30, 2009. President and CEO Stephen MacMillan said the increased dividend reflects the company's continued growth and strong... more

Greetings from Suzhou: Notes from Third International Congress of the Chinese Orthopedic Association BY JOHN MCCORMICK, NOVEMBER 17, 2008

Greetings from Suzhou! Yes that Suzhou - in China. To follow the orthopedic surgeon, China was the place to be this month. While we know this formidable nation always surpasses expectations, we were truly blown away by the Chinese Orthopedic... more

Pain a Cause, Not Just a Symptom, of Arthritis BY LAUREN UZDIENSKI, NOVEMBER 13, 2008

A recent study from the journal Arthritis and Rheumatism presented some illuminating data on arthritis--in particular, the pain that characterizes the condition is more than a symptom, with pain signals actually causing and exacerbating tissue degeneration as they're processed by... more

Musculoskeletal News Roundup 13-Nov-08 BY LAUREN UZDIENSKI, NOVEMBER 13, 2008

Earnings aap Implantate AG reported sales for the first nine months of 2008 of EUR 24.2 million ($35.0 million), up 30% from the same period last year. The company attributed the sales growth to the Traumatology & Orthopaedics division, where... more

Traumatized Muscle Offers Clues to Cell Repair and Regeneration BY LAUREN UZDIENSKI, NOVEMBER 3, 2008

A study published this month in JBJS identifies progenitor cells in traumatized human tissue - which could lead to new options in tissue engineering. The authors point out that while there are multiple sources of progenitor cells (such as bone... more

Musculoskeletal News Roundup 30-Oct-08 BY LAUREN UZDIENSKI, OCTOBER 30, 2008

Earnings Exactech reported 3Q:08 revenues of $37.9 million, missing revenues by $0.9 million and representing an increase of 27% over the year-ago period. Among segments, knee revenue increased 16%; organic hip implant revenue increased 8%; biologic services revenue increased 12%;... more

Musculoskeletal News Roundup 22-Oct-08 BY LAUREN UZDIENSKI, OCTOBER 22, 2008

Earnings CONMED reported 3Q:08 revenues of $179.4 million, up 9% over the year-ago period and beating estimates by $2.95 million. Arthroscopy was up 18% (17% constant currency), contributing $69.5 million to total sales. On a non-GAAP basis, diluted earnings per... more

Musculoskeletal News Roundup 16-Oct-08 BY LAUREN UZDIENSKI, OCTOBER 16, 2008

Earnings Biomet reported FQ1:09 revenues of $607.0 million, up 13% (9% constant currency) over the year-ago period. Excluding special charges, adjusted operating income was $171.6 million for FQ1:09, up 12% over FQ1:08. Among segments, reconstructive reported $449.3 million in sales,... more

Musculoskeletal News Roundup 2-Oct-08 BY LAUREN UZDIENSKI, OCTOBER 2, 2008

M&A Arthro Kinetics announced that they are pursuing a potential asset sale. The company said this week that their current $5.0 million cash balance was not sufficient to sustain operations. Tecomet has been acquired from Cardinal Health by Charlesbank Capital... more

Musculoskeletal News Roundup 25-Sept-08 BY LAUREN UZDIENSKI, SEPTEMBER 25, 2008

Funding Anulex Technologies, Inc. secured a $7.0 million growth capital term loan from Silicon Valley Bank. The company plans to use the proceeds to further their R&D efforts, complete their clinical study and expand their sales force. Anulex markets the... more

Musculoskeletal News Roundup 18-Sept-08 BY LAUREN UZDIENSKI, SEPTEMBER 18, 2008

M&A BoneSupport acquired Ultrazonix, the developer of an ultrasound-based treatment for alleviating pain associated with herniated discs. The product is FDA-cleared and CE-marked. Financial terms were not disclosed. Funding Formae received an investment of $0.5 million from BioAdvance, the Biotechnology... more

Researchers Show How OA Breaks Down Cartilage BY LAUREN UZDIENSKI, SEPTEMBER 17, 2008

Researchers have long suspected that the signaling protein beta-catenin plays a role in how osteoarthritis breaks down cartilage, but until now there has been no definitive research linking the protein to OA. A study from the University of Rochester Medical... more

Arthroscopic Knee Surgery for OA... Is It Worth It? BY JOHN MCCORMICK, SEPTEMBER 16, 2008

Last week, the New England Journal of Medicine published a study that more or less said "no". In cautionary scientific parlance, the study concluded that "arthroscopic surgery for osteoarthritis of the knee provides no additional benefit to optimized physical and... more

Musculoskeletal News Roundup 11-Sept-08 BY LAUREN UZDIENSKI, SEPTEMBER 11, 2008

M&A Wright Medical Group, Inc. acquired the RAYHACK System for wrist reconstruction, which consists of "procedure-specific bone-cutting guides and fixation plates that allow precise shortening and repositioning of the radius and ulna." The system will be available in the U.S.... more

What's in Store for Stryker? 07 Settlement Gives Clues BY LAUREN UZDIENSKI, SEPTEMBER 10, 2008

Stryker's bold move a few weeks ago of suing the DOJ over an ongoing investigation has been the subject of wide speculation, and while little is known for sure about what prompted their action, last year's settlement offers some insight.... more

U.K. Study Finds 1 in 75 Patients Undergo Large Joint Revision BY LAUREN UZDIENSKI, SEPTEMBER 8, 2008

Data from about 160,000 U.K. patients who received hip or knee replacements between 2003 and 2006 show an overall revision rate of one in 75, or 1.4%. Overall, this rate is low, but it was affected by the type of... more

Hand Transplants "Exceed Expectations" BY LAUREN UZDIENSKI, SEPTEMBER 3, 2008

This month, the Journal of Hand Surgery features a report on the two American patients who received allogenic hand and forearm transplants and are performing beyond expectations at 9 and 7 years post-operatively, respectively. Their progress helps demonstrate that transplanting... more

SPORT Subgroup Analysis Shows Discectomy Outcomes Vary by Herniation Level BY LAUREN UZDIENSKI, SEPTEMBER 2, 2008

A new study published in JBJS evaluated results from one arm of the SPORT trial to see if herniation level affected discectomy outcomes. The authors undertook the study after a recent randomized trial conducted by Dr. Heikki Osterman et al... more

Beyond Building Bones, BMP-7 May Fight Obesity BY LAUREN UZDIENSKI, AUGUST 25, 2008

Researchers at Boston's Joslin Diabetes Center have identified what could be a surprising new way to treat obesity - BMP-7, the bone growth protein familiar to the orthopedic sector as the active protein in Stryker's OP-1, may also support weight... more

Musculoskeletal News Roundup 21-Aug-08 BY LAUREN UZDIENSKI, AUGUST 21, 2008

Earnings Kensey Nash reported FQ4:08 revenues of $22.0, representing a 29% increase over FQ4:07 and beating estimates by $1.0 million. Biomaterials were up 37% to $13.3 million, which was attributed to strong growth in the orthopedic and cardiovascular product lines.... more

Musculoskeletal News Roundup 14-Aug-08 BY LAUREN UZDIENSKI, AUGUST 14, 2008

Earnings BioMimetic Therapeutics reported a 2Q:08 net loss of $9.2 million, or $0.50 per diluted share, widening from a net loss of $6.4 million, or $0.35 per diluted share, in 2Q:07. Clinical highlights for the quarter include the announcement of... more

"Lessons Learned" from a Hip Resurfacing IDE BY LAUREN UZDIENSKI, AUGUST 13, 2008

Hip resurfacing devices have only become available in the U.S. in the last two years (Smith & Nephew introduced the BHR in 2006 and Stryker began distributing Corin's Cormet in 2007), and with the relatively recent launch comes an "incomplete"... more

Musculoskeletal News Roundup 7-Aug-08 BY LAUREN UZDIENSKI, AUGUST 7, 2008

Earnings Alphatec Spine, Inc. reported consolidated revenues for 2Q:08 of $23.9 million, an increase of 27% from the $18.8 million reported in 2Q:07. U.S. revenues for 2Q:08 were $19.4 million, an increase of 20% from the $16.2 million reported in... more

DOJ Settlement Echoes in Reduced Industry Research Funding BY LAUREN UZDIENSKI, AUGUST 4, 2008

Orthopedics Today is reporting that following the DOJ investigation, research institutions are seeing a slowdown in industry funding (with one unnamed Big-Five company withdrawing "nearly all" of its funding) that could decline even further in 2009. This reduction in funding... more

MIT Study Advances Non-Surgical Stem Cell Treatments for Spinal Cord Injuries BY HAL BRIGHAM, JULY 30, 2008

A recent joint study out of MIT's Picower Institute for Learning and Memory and the Karolinska Institute in Sweden may pave the way for the development of revolutionary, non-surgical treatments for spinal cord injuries. Headed by Konstantinos Meletis, a postdoctoral... more

Musculoskeletal News Roundup 24-July-08 BY LAUREN UZDIENSKI, JULY 24, 2008

Earnings Anika Therapeutics reported 2Q:08 revenue of $8.38 million, representing a 32% increase over 2Q:07 but missing estimates by $0.4 million. The company attributed sales growth to the strength of the Orthovisc line. Net income for 2Q:08 was $0.81 million,... more

Study Finds Hip and Knee Arthroplasty Worthwhile for the Elderly BY HAL BRIGHAM, JULY 21, 2008

A study published in the July 14, 2008 issue of Archives of Internal Medicine contends that hip and knee arthroplasty surgeries may be more beneficial to elderly patients than once believed. The study reports that surgery is not only more... more

FzioMed's Oxiplex "Not Approvable" According to FDA Panel BY DAVID KRESSEL, JULY 16, 2008

On Tuesday, we attended the FDA's Orthopaedic & Rehabilitative Devices Panel, Oxiplex/SP was voted "Not Approvable" by a 5-2 vote, based largely on the sponsoring company's inability to definitively demonstrate product effectiveness. The two dissenters would have voted it "Approvable... more

ACL Repair for Young, Active Patients: Heightened Risks Create Opportunity for Regenerative Technologies BY LAUREN UZDIENSKI, JULY 16, 2008

Researchers at the Mississippi Sports Medicine and Orthopaedic Center have found a failure rate nearing 24% for ACL reconstruction in young, athletic patients, according to a new study. Of 61 patients aged 15-39 who underwent ACL reconstruction, 14 were deemed... more

JBJS: ReGen's Collagen Meniscus Implant Improves Clinical Outcomes for Some Patients BY LAUREN UZDIENSKI, JULY 8, 2008

A new JBJS study comparing ReGen Biologics' collagen meniscus implant, Menaflex, with partial meniscectomy was published this week, and the publication comes as a rare bit of good news for the struggling ReGen. At 311 patients, the multi-center study was... more

Musculoskeletal News Roundup 3-July-08 BY LAUREN UZDIENSKI, JULY 3, 2008

Regulatory Interventional Spine announced that the FDA has conditionally approved its IDE application for the PercuDyn System, pending the company providing some additional information to the FDA. CEO Walter Cuevas commented that the company will now begin collecting data to... more

Musculoskeletal News Roundup 26-Jun-08 BY LAUREN UZDIENSKI, JUNE 27, 2008

Earnings Symmetry Medical reported 1Q:08 revenue of $101.9 million, up 57% from the year-ago period. Revenue was positively affected by the recent acquisitions of TNCO, Inc., Specialty Surgical Instrumentation Inc. and DePuy Orthopaedics, Inc.'s Massachusetts manufacturing facility. Net income for... more

In3 on the State of the Medical Device Industry BY LAUREN UZDIENSKI, JUNE 24, 2008

China was a hot topic at the In3 Medical Device Summit, but one event focused on the device industry more broadly: where devices have been and where they're heading. The presentation, led by David Cassak of Windhover Information, described the... more

Twin Study Shows that Disc Degeneration May be Genetic BY LAUREN UZDIENSKI, JUNE 10, 2008

Results from the Finnish Twin Spine Study show that disc degeneration may not be the result of physical strain, but genetically determined. The study, which was initiated in 1991, examined 147 pairs of identical and 153 pairs of fraternal male... more

Musculoskeletal News Roundup 5-June-08 BY ARMELLE WIART, JUNE 6, 2008

Earnings Integra LifeSciences reported its financial results for the first quarter ending March 31, 2008. Total revenues were approximately $156.0 million, reflecting an increase of $33.0 million, or 27%, over the first quarter of 2007. Adjusted net income for the... more

Musculoskeletal News Roundup 29-May-08 BY ARMELLE WIART, MAY 29, 2008

M&A Kinetic Concepts, Inc. announced that it completed its acquisition of LifeCell Corporation. At the time of the expiration of the tender offer, 31.1 million shares of LifeCell common stock had been tendered representing approximately 90.75% of the outstanding shares... more

JBJS: Can Orthopedic Surgical Trials Be Blinded? BY LAUREN UZDIENSKI, MAY 28, 2008

The double-blinded study is the gold standard of clinical research, but designing surgical trials to those standards can be difficult and often evokes such questionable options as sham surgery. However, one analysis of orthopedic surgical trials found that blinding may... more

Musculoskeletal News Roundup 15-May-08 BY LAUREN UZDIENSKI, MAY 15, 2008

Earnings aap Implantate AG announced 1Q:08 revenues of EUR 8.0 million ($12.64 million), up 36% over the year-ago period. The company attributed the growth to a 146% increase in sales in its Trauma & Orthopaedics division, which contributed EUR 3.7... more

Promising ChondroCelect Data Shows Structural Superiority at Three Years BY LAUREN UZDIENSKI, APRIL 28, 2008

Just over a year ago, TiGenix published 12 and 18-month results from their ChondroCelect clinical trial that showed advantages to the ACI treatment when compared to microfracture. Now the company has released further data showing that three years following treatment,... more

Musculoskeletal News Roundup 10-Apr-08 BY LAUREN UZDIENSKI, APRIL 10, 2008

M&A Kinetic Concepts, Inc. announced plans to acquire LifeCell for $1.7 billion, or $51.00 per share, which represents an 18% premium over LifeCell's closing price on Friday and a 26% premium over the 90-day volume weighted average trading price. KCI... more

BioMimetic Dives on FDA Communication to J&J BY DAVID KRESSEL, APRIL 2, 2008

BioMimetic Therapeutics' shares dove sharply last week (and recovered somewhat less sharply) because the FDA raised the possibility that the active ingredient of all of the company's products, PDGF (Platelet-Derived Growth Factor), caused cancer. From Thursday's intraday high price per... more

Encouraging Product Adoption as the Bar Rises for New Technology BY LAUREN UZDIENSKI, APRIL 1, 2008

In the past decade, the use of intramedullary nails in the treatment of hip fractures has increased substantially, despite a lack of evidence supporting the benefits of their use. Additionally, use of the nails varies by geography, differing more than... more

Musculoskeletal News Roundup 27-Mar-08 BY LAUREN UZDIENSKI, MARCH 27, 2008

Earnings DJO Inc., formerly ReAble Therapeutics, reported 4Q:07 net sales of $170.7 million, a 97% increase over 4Q:06; the growth rate was due primarily to acquisitions, including ReAble's merger with DJO. The company reported an actual net loss of $57.3... more

Hibernating Bears Offer Clues to Osteoporosis BY LAUREN UZDIENSKI, MARCH 24, 2008

Ever wonder how bears can hibernate without suffering from the softened, weakened bones that affect humans following periods of inactivity? Neither did we, until the Wall Street Journal (subscription required) brought it to our attention. The question occurred to nature-lover... more

When Evaluating Knee OA, Patient Gender Affects Whether a Physician Recommends Surgery BY LAUREN UZDIENSKI, MARCH 20, 2008

According to a new study reported on by the New York Times, patient gender appears to influence whether physicians recommend they have a knee replaced. In a Canadian study, a male patient was told twice as often to have the... more

Consumer Spending on Spine Increases, But Pain Persists; More Data is Needed on Treatment Options BY LAUREN UZDIENSKI, FEBRUARY 25, 2008

Consumer spending for spinal treatments rose 65% from 1997 to 2005, faster than overall health spending, with patients spending $86 billion to treat back and neck problems. These treatments included drugs, outpatient procedures, ER visits and surgery. However, back pain... more

Musculoskeletal News Roundup 21-Feb-08 BY LAUREN UZDIENSKI, FEBRUARY 21, 2008

Earnings ArthroCare reported 4Q:07 revenues of $87.5 million, beating estimates by $1.7 million, representing a 25% increase over the year-ago period. Net income was $14.5 million, or $0.50 per diluted share, missing estimates by a penny and representing a 78%... more

SPORT Tests Surgery in Spinal Stenosis Patients; Surgery Favored BY LAUREN UZDIENSKI, FEBRUARY 19, 2008

Data from the eagerly-anticipated final arm of the SPORT trial was released today. Results showed that patients receiving decompressive laminectomy for the treatment of spinal stenosis showed improved outcomes following the procedure. Prior arms of the $21 million SPORT trial... more

Musculoskeletal News Roundup 14-Feb-08 BY LAUREN UZDIENSKI, FEBRUARY 14, 2008

Earnings Hanger Orthopedic Group reported 4Q:07 net sales of $170.8 million, beating estimates by $7.5 million and representing an 11% over the year-ago period. Revenue growth was attributed to an increase in same-center sales from Hanger's patient care business, an... more

Musculoskeletal News Roundup 7-Feb-08 BY LAUREN UZDIENSKI, FEBRUARY 7, 2008

Earnings Smith & Nephew announced 4Q:07 revenues of $967.0 million, beating estimates of $933.0 million and reflecting a 25% (reported) increase over 4Q:06. Adjusted earnings per share was $0.16, in line in estimates and up 10% over the year-ago period.... more

Musculoskeletal News Roundup 31-Jan-08 BY LAUREN UZDIENSKI, JANUARY 31, 2008

Earnings Kensey Nash reported FQ2:08 total revenues of $19.6 million, missing estimates by $0.05 million and up 14% over the year-ago period. Net sales of biomaterials products increased 15% to $11.5 million, which the company attributed to orthopedic sales. The... more

The New York Times Questions Prodisc, Surgeons, Hospitals, Industry and FDA BY DAVID KRESSEL, JANUARY 30, 2008

In the January 30th issue of the New York Times, healthcare reporter Reed Abelson takes a critical look at spine surgery, and in particular a novel device called Prodisc in an article titled "Financial Ties Are Cited as Issue in... more

Newly-Discovered Protein Can Control Bone Growth BY LAUREN UZDIENSKI, JANUARY 25, 2008

According to a new study, researchers at McGill University discovered the mechanism by which the protein osteocrin controls bone growth. Mice studies into osteocrin were conducted at Phenogene and Enobia Pharma as well as in Dr. Pierre Moffatt's lab at... more

Musculoskeletal News Roundup 10-Jan-08 BY LAUREN UZDIENSKI, JANUARY 10, 2008

M&A ArthroCare Corp. acquired DiscoCare, Inc., whom the company describes as "a third-party billing and reimbursement service provider," for $25 million in cash plus potential future milestone payments. The company says, "This acquisition will allow ArthroCare to significantly expand its... more

Revision Total Hip Arthroplasty Benefits Patients 80+ BY LAUREN UZDIENSKI, JANUARY 7, 2008

Testing a common belief that revision total hip arthroplasty is associated with a high complication rate in the very elderly, researchers at Philadelphia's Rothman Institute for Orthopedics retrospectively evaluated outcomes in over 300 THA patents. There were two groups of... more

Musculoskeletal News Roundup 29-Nov-07 BY LAUREN UZDIENSKI, NOVEMBER 29, 2007

Regulatory Amedica received FDA clearance for their Valeo™ Pedicle Screw system, a low profile and modular pedicle screw system intended for non-cervical pedicle fixation from the T1 through L5. Corin announced FDA clearance for additional sizes of its Cormet hip... more

Musculoskeletal News Roundup 1-Nov-07 BY LAUREN UZDIENSKI, NOVEMBER 1, 2007

Earnings DJO reported 3Q:07 net revenues of $119.8 million, up 5.8% over 3Q:06. Excluding a 2006 revenue benefit from shipping terms and clearing of product backorders associated with Aircast, 3Q:07 revenue was up 7.6% to $121.8 million, in line with... more

Musculosketal News Roundup 25-Oct-07 BY LAUREN UZDIENSKI, OCTOBER 25, 2007

Earnings ArthroCare Corp. reported 3Q:07 total revenues of $78.5 million, an increase of 21% over the comparable quarter. Revenues missed estimates by $0.11 million. The company reported net income of $11.1 million, or $0.39 per share, up 28% over 3Q:06... more

Musculoskeletal News Roundup 18-Oct-07 BY LAUREN UZDIENSKI, OCTOBER 18, 2007

Earnings Biomet reported FQ1:08 sales of $552.3 million, up 9% over the comparable quarter. The company reported a net loss for the quarter of $42.9 million, down from an income of $104.4 million for FQ1:07. The company attributed the loss... more

JBJS: ACI, Microfracture Show Comparable Outcomes at Five Years BY LAUREN UZDIENSKI, OCTOBER 8, 2007

JBJS published results from a prospective, randomized Norweigan trial where 80 patients were selected to receive either autologous chrondocyte implantation (ACI) or microfracture for the treatment of chronic cartilage defects. There were 40 patients in each group. - Five-year follow-up... more

Musculoskeletal News Roundup 4-Oct-07 BY LAUREN UZDIENSKI, OCTOBER 4, 2007

M&A Orthofix acquired the rights to all of the intellectual property related to the InSWing™ interspinous process spacer. InSWing is designed to relieve pain associated with lumbar spinal stenosis and can be used in a minimally invasive surgical procedure. Orthofix... more

Musculoskeletal News Roundup 20-Sept-07 BY LAUREN UZDIENSKI, SEPTEMBER 18, 2007

Earnings AOI Medical reported a 1H:07 loss of $1.8 million, increasing from a loss of $0.97 million in the comparable half. The company attributed the loss to increased expenses. They expect their product, the Balloon Assisted Management of Spine Fractures,... more

Pill Reduces Risk of Blood Clots After Hip Replacement BY LAUREN UZDIENSKI, SEPTEMBER 18, 2007

As published in the Lancet this week, results of a new trial showed that a pill called dabigatran etexilate (DE) was as effective as the injected drug enoxaparin in reducing the risk of blood clots following total hip replacement. DE... more

JBJS: U.K. NICE Guidelines Have "Little Impact" on Surgeons' Product Selection BY LAUREN UZDIENSKI, SEPTEMBER 10, 2007

The July U.K. edition of JBJS reported results of a study evaluating the impact of the U.K.'s National Institute for Health and Clinical Excellence (NICE) guidelines for hip replacements. NICE publishes guidelines to promote "good health and the prevention and... more

Musculoskeletal News Roundup 6-Sept-07 BY LAUREN UZDIENSKI, SEPTEMBER 6, 2007

Regulatory Inion Oy received FDA approval for its implant material BioRestore in dental and cranio-maxillofacial applications. The product is designed to fill bony voids or gaps in the skeleton. BioRestore is currently being reviewed by the FDA for use in... more

Overcoming the Challenges of Randomized Orthopedic Clinical Trials BY LAUREN UZDIENSKI, AUGUST 14, 2007

Despite randomized clinical trials' status as the most scientifically rigorous of potential research designs, RCTs make up a relatively small percentage of published orthopedics research. More randomized trials are being conducted now than in the past, but ongoing concerns about... more

JBJS: Specialty Orthopedic Hospitals Offer Better Surgical Outcomes BY LAUREN UZDIENSKI, AUGUST 7, 2007

In the past few years, specialty hospitals have been the subject of controversy, criticized for accepting only the most profitable patients with the lowest risk of complications and for their lack of emergency and charity care. However, a retrospective study... more

Musculoskeletal News Roundup 26-July-07 BY LAUREN UZDIENSKI, JULY 26, 2007

Earnings Stryker reported revenues of $1.46 billion, beating estimates of $1.44 billion and increasing 16% from $1.26 billion in 2Q:06. 2Q:07 earnings were $269.1 million, or $0.65 per share, beating estimates of $0.61 and up from $0.52 in the comparable... more

Musculoskeletal News Roundup 19-July-07 BY LAUREN UZDIENSKI, JULY 19, 2007

M&A DJO announced on Monday plans for merger with ReAble (formerly Encore Medical). ReAble will acquire all outstanding shares of DJO stock, a transaction valued at approximately $1.6 billion and including the assumption of debt. The transaction will be funded... more

Encouraging Data for GEM OS1 BY LAUREN UZDIENSKI, JULY 19, 2007

At the AOFAS meeting last week, BioMimetic Therapeutics reported further positive interim data from its ongoing clinical trials of GEM OS1 in foot and ankle fusion indications. The U.S. arm of the study is a randomized, prospective, controlled pilot study... more

CMS Revises their Clinical Trial Policy; More Changes to Come BY LAUREN UZDIENSKI, JULY 13, 2007

On Monday, CMS released a brief Decision Memo on changes to the agency's Clinical Trials Policy. The proposed decision was first announced in April and followed by a public comment period. The memo notes two important changes. One, the final... more

Orthopedic News Roundup 28-June-07 BY LAUREN UZDIENSKI, JUNE 28, 2007

Regulatory Life Spine announced 510(k) clearance for its static anterior cervical plating system Neo®-SL. The system features an integrated lock that allows bone screws to be securely fixated without any additional locking components. The FDA approved new labeling for Genzyme's... more

Orthopedic News Roundup 7-June-07 BY LAUREN UZDIENSKI, JUNE 7, 2007

M&A The private equity consortium set to acquire Biomet increased its buyout offer to $46.00 per share in cash, or an equity value of $11.4 billion. The new offer represents a 32.3% premium over the April 2006 common stock closing... more

Orthopedic News Roundup 31-May-07 BY LAUREN UZDIENSKI, MAY 31, 2007

Regulatory CMS released a proposed non-coverage decision for lumbar artificial disc replacements following a review of Synthes' Pro-Disc-L. The agency found that LADR is not reasonable and necessary for Medicare recipients over 60 based on lack of relevant data and... more

Surgery Favored in Latest SPORT Data BY LAUREN UZDIENSKI, MAY 30, 2007

Spinal fusion is evaluated in the second of three SPORT studies, and patients who selected the surgery to treat degenerative spondylolisthesis had better outcomes when compared with nonsurgical treatment. However, when the results were analyzed on an intention-to-treat basis, there... more

Studies with Commercial Funding, U.S. Authors More Likely to be Published BY LAUREN UZDIENSKI, MAY 16, 2007

In what may be the first study to evaluate peer-review bias in orthopedics based on submitted, rather than published, studies, Joseph Lynch et al consider associations between scientific and nonscientific variables and outcome as well as acceptance for publication. Lynch... more

Orthopedic News Roundup 10-May-07 BY LAUREN UZDIENSKI, MAY 10, 2007

Earnings Biologics Integra LifeSciences announced 1Q:07 revenues of $123.0 million, beating estimates of $119.25 million and reflecting a 60% increase over 1Q:06. Net income for the quarter was $9.07 million, or $0.33 per share, meeting analysts' estimates. President and CEO... more

Orthopedic News Roundup 3-May-07 BY LAUREN UZDIENSKI, MAY 3, 2007

Earnings Spine Kyphon reported that worldwide revenues in 1Q:07 increased 40% to $128.1 million, which includes $18.1 million in X-STOP® Interspinous Process Decompression (IPD®) sales from the St. Francis acquisition. In the U.S., revenues increased 34% to $101.1 million, while... more

Orthopedic News Roundup 26-Apr-07 BY LAUREN UZDIENSKI, APRIL 26, 2007

Earnings Large Joints Zimmer reported income of $233.4 million, or $0.98 per share, beating estimates of $0.93. The quarter compares to a profit of $205.6 million, or $0.82 per share in 1Q:06. Revenue rose 10% to $950.2 million from $860.4... more

FDA Makes Post-Approval Device Study Info Public BY LAUREN UZDIENSKI, APRIL 10, 2007

Plans for more rigorous post-marketing policy are underway at the FDA with a new website that tracks post-approval device studies. The website names the manufacturer, device, study description and study status. There is no specific info on clinical studies because... more

Orthopedic News Roundup 29-Mar-07 BY LAUREN UZDIENSKI, MARCH 29, 2007

Earnings BioMimetic Therapeutics announced 4Q:06 financial results, reporting a net loss of $5.3 million or $0.34 per share and beating analysts' estimates of a loss of $0.37 per share. This compares to a net loss of $9.2 million, or $5.82... more

Orthopedic News Roundup 22-Mar-07 BY LAUREN UZDIENSKI, MARCH 22, 2007

Earnings Inion announced year-end results for 2006 on Wednesday, reporting a 25% decline in revenues. 2006 sales totaled EUR 5.7 million, compared with EUR 7.6 million in 2005. R&D spending increased 17% to EUR 5.6 million from EUR 4.8 million... more

JBJS: Conflicts of Interest Associated with Favorable Research Outcomes BY LAUREN UZDIENSKI, MARCH 19, 2007

More than 40% of investigators presenting data at the 2001 and 2002 Annual Meetings of AAOS reported conflicts of interest, and a new study in this month's JBJS shows that those conflicts were associated with positive study findings. Though investigators... more

New Safety Assurances for Allograft BY LAUREN UZDIENSKI, MARCH 5, 2007

Following a handful of scandals, donated human tissue has shouldered a reputation for being unsafe and unreliable. However, new data demonstrates one company's efforts to process sterile and high-performance allografts. At a sports medicine conference last fall, Dr. Fred Cushner... more

Orthopedic News Roundup 22-Feb-07 BY LAUREN UZDIENSKI, FEBRUARY 22, 2007

Earnings Medtronic reported 3Q:07 (ended 1/26/07) Spinal and Navigation revenue of US $629.0 million, and the Spinal segment increased 12% over 3Q:06. Growth was attributed to the Biologics product line and the CD HORIZON® LEGACY™ family of products, which includes... more

The Quest to Regenerate Cartilage: TiGenix and Osiris Reveal Clinical Results BY ARIELLA P. GOLOMB, MD, FEBRUARY 20, 2007

Yesterday, TiGenix, a Belgium-based biomedical company, announced the results of their phase III multi-center randomized trial of ChondroCelect as first-line treatment for symptomatic knee cartilage defects. ChondroCelect is designed to be used in combination with autologous chondrocyte implantation (ACI) surgery... more

Orthopedics News Roundup 15-Feb-07 BY LAUREN UZDIENSKI, FEBRUARY 15, 2007

Earnings Tutogen announced results for first fiscal quarter ending December 31, 2006. Total revenues increased 43% to $11.5 million, compared to $8.0 million in the comparable quarter of fiscal year 2006. U.S. revenues increased 50%, and international revenues increased 27%... more

Orthopedics News Roundup 8-Feb-07 BY LAUREN UZDIENSKI, FEBRUARY 8, 2007

Earnings Biologics Regeneration Technologies, Inc. reported 4Q:06 revenues of $19.1 million, down 5% from $20.1 million in 4Q:05. The Company reported net loss of $6.7 million, compared to a net lossn of $1.7 million for 4Q:05. Net loss per diluted... more

Orthovita to Pursue 510(k) for Cortoss, Despite Pivotal Study BY LAUREN UZDIENSKI, FEBRUARY 5, 2007

Orthovita announced this morning that they would apply for 510(k) approval for their Cortoss® Bone Augmentation Material, scrapping a bid for PMA approval. Cortoss is not available in the U.S., but the product has a CE mark in Europe. Applied... more

Orthopedics News Roundup 25-Jan-07 BY LAUREN UZDIENSKI, JANUARY 25, 2007

Earnings Stryker reported a 28% increase in sales of orthopedic implants and endoscopy products for 4Q:06. The Company earned $227.9 million, or 55 cents per share, meeting analysts' estimates, compared with a profit of $178.4 million, or 43 cents per... more

Orthopedics News Roundup 18-Jan-07 BY LAUREN UZDIENSKI, JANUARY 18, 2007

Earnings Lifecore Biomedical reported earnings for the second quarter ending December 31, 2006. Net income fell to $1.37 million, or $.10 per diluted share during the quarter from $1.39 or $.10 per diluted share, in the quarter ending December 31,... more

Orthopedic News Roundup 11-Jan-07 BY LAUREN UZDIENSKI, JANUARY 11, 2007

M&A Paragon Medical has entered into an agreement to acquire OMC Precision Products and Tutela Medicus. OMC provides machining, finishing and assembly of implants, primarily for the spinal and neurological markets, and Tutela offers product development services to device manufacturers... more

MCAC Debates Clinical Research Coverage BY LAUREN UZDIENSKI, DECEMBER 19, 2006

We attended last Wednesday's MCAC panel in Baltimore, convened to discuss revisions to CMS' clinical research policy. The panel recommended changes to the terminology and scope of CMS coverage; voting questions covered the definition of a good clinical study, changes... more

Orthopedic News Roundup 14-Dec-06 BY LAUREN UZDIENSKI, DECEMBER 14, 2006

Regulatory CryoLife received FDA 510(k) clearance for its ProPatch™ Soft Tissue Repair Matrix, an announcement that drove its stock up 9%. Among other applications, ProPatch can be used to reinforce tissues repaired by sutures or by suture anchors during tendon... more

Orthopedic News Roundup 30-Nov-06 BY LAUREN UZDIENSKI, NOVEMBER 30, 2006

Earnings ORTHOsoft reported 3Q:06 revenues of CAN $3.8 million (US $3.3 million), up 59% from CAN $2.4 million (US $2.1 million) in 3Q:05. ORTHOsoft manufactures computer aided orthopedic surgery devices, and they attribute the 3Q:06 growth to increased navigation systems... more

Rutgers Researcher Seeks Credibility for Chinese Spine Trials BY LAUREN UZDIENSKI, NOVEMBER 29, 2006

In 2005, Nature reported that companies were "queuing up" to conduct clinical trials in China, where a large population simplifies the enrollment process and research could be conducted at lower cost than in the U.S. Similar trends can be seen... more

Intial SPORT Trial Outcomes Subject to Interpretation, but Tend to Favor Surgery BY JOHN MCCORMICK, NOVEMBER 22, 2006

The first arm of the Spine Patients Outcome Research Trial ("SPORT") study was released by the Journal of the American Medical Association yesterday. The $13.5 million NIH funded SPORT study has been designed to determine the efficacy of spine surgery... more

Orthopedic News Roundup 16-Nov-2006 BY LAUREN UZDIENSKI, NOVEMBER 16, 2006

Earnings: Langer reported their 3Q:06 results on Tuesday, which included a net loss of approximately $553,000, or $.06 per share on a fully diluted basis. Compared to 3Q:05, there was a net income $236,000, or $.02 per share on a... more

Synvisc To Share Reimbursement Code BY ARIELLA P. GOLOMB, MD, OCTOBER 31, 2006

In a press release yesterday, Genzyme, maker of Synvisc, announced a CMS decision that would group all viscosupplementation products into the same reimbursement code in January 2007. The company stated that they would fight hard to dispute this decision (through... more

How Are Orthopedic Surgeons Being Incentivized For Academic Productivity? BY ARIELLA P. GOLOMB, MD, OCTOBER 16, 2006

In the wake of demands for increasing clinical volume, decreases in physician income and increasing malpractice costs, it is even more critical to incentivize physicians to perform academic activities that do not directly generate revenue (teaching, research and service) but... more

Orthopedic News Roundup 12-Oct-06 BY HUYEN NGUYEN, OCTOBER 12, 2006

Earnings Update: CryoLife provided an update on its 3Q:06 projected revenues, which are estimated at ~$20 million, a 22% increase over the comparable quarter of 2005. In 3Q:06, its tissue processing revenues were ~$10.3 million, an increase of 41%, and... more

Medical Device Regulatory Updates in China and Japan BY HUYEN NGUYEN, OCTOBER 9, 2006

Asia's continued economic growth makes it an attractive market for both the sale and manufacture of medical devices. Pacific Bridge Medical, a medical consulting firm focusing on business development and regulatory affairs in Asia, recently published an article on the... more

Will the FDA Be Able to Regulate Nanotechnology? BY ARIELLA P. GOLOMB, MD, OCTOBER 6, 2006

Nanotechonology is clearly making strides in the orthopedic marketplace. The question is, will the FDA will be able to keep up? Report Claims FDA Not "Nano Ready" Yesterday, Michael Tayor, an attorney and former Deputy Commissioner for Policy at the... more

NASS Notes BY ARIELLA P. GOLOMB, MD, SEPTEMBER 29, 2006

With the 2006 NASS meeting winding down, we thought we'd share some highlights from Seattle. SPORT Clinical Trial Session a Tease On Wednesday, the two-hour, much-anticipated session on SPORT results focused on SPORT background information - but not the data... more

Medtronic's Disc Recommended for FDA Approval BY ARIELLA P. GOLOMB, MD, SEPTEMBER 20, 2006

Yesterday's FDA Orthopedic and Rehabilitation Devices advisory panel unanimously recommended approval of Medtronic's PRESTIGE Cervical Disc System. After reviewing the 24 month, ~500 patient multi-center randomized clinical trial data, Wall Street Journal (subscription required) reported that the FDA panel concluded... more

BioMimetics' Data Impresses BY DAVID KRESSEL, SEPTEMBER 19, 2006

Dr. William Giannobile, a professor of dentistry at the University of Michigan, presented new data on BioMimetics' only approved product, GEM21S, at the American Academy of Periodontology meeting in San Diego yesterday. GEM21S is short for "Growth-factor Enhanced Matrix," a... more

Orthopedic News Roundup 14-Sept-06 BY HUYEN NGUYEN, SEPTEMBER 14, 2006

Appointment: Orthovita, Inc. has appointed Albert J. Pavucek, Jr. Vice President Corporate Controller. Mr. Pavucek was with PDI, Inc. serving as Vice President, Finance and Operations. Awards & Recognition: Smith & Nephew plc announced that two of its products, the... more

Orthopedic News Roundup 7-Sept-06 BY HUYEN NGUYEN, SEPTEMBER 7, 2006

Appointment: Ranier Technology Limited has appointed John C. Moran to its Board of Directors. Previously, Mr. Moran was a President of Synthes Spine and a Director of Spine Solutions, Inc. Active Implants Corporation (AIC) has hired Richard Treharne, PhD. as... more

Botulinum Toxin's Orthopedic Applications BY ARIELLA P. GOLOMB, MD, AUGUST 22, 2006

You've heard about Botox being used to reduce wrinkles, but did you know it can also be used by orthopedic surgeons? "Botulinum toxin and its orthopaedic applications" was reviewed in this month's British volume of the Journal of Bone and... more

Orthopedic News Roundup 10-Aug-06 BY HUYEN NGUYEN, AUGUST 10, 2006

Earnings: Biologics: Orthovita reported 2Q:06 product sales came in at $11.2 million, up 32% compared to 2Q:05. On a non-GAAP basis net loss for the quarter was $5.1 million, or a loss of $0.10 per share. The Company did not... more


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